英文药名：ROPION Intravenous(Flurbiprofen axetil) 中文药名：氟比洛芬注射剂 生产厂家：科研制药 ロピオン静注50mg 治疗类别名称 非甾体镇痛药用于静脉注射 商標名 ROPION Intravenous 50mg 一般名 Flurbiprofen axetil(フルルビプロフェン　アキセチル) 化学名 (±)-1-acetoxyethyl 2-(2-fluoro-4-biphenylyl)propionate 分子式 C19H19FO4 分子量 330.35 構造式 性状 在油性液体无色至淡黄色，有一种特有的香味，味微苦略氟比洛芬酯。 í混溶用丙酮或乙醇（99.5）。 和几乎不溶于水。 示没有旋光性（99.5）溶液（1→100）乙醇。 药理毒理 1．药理作用 本品是以脂微球为药物载体的非甾体类镇痛剂。药物进入体内靶向分布到创伤及肿瘤部位后，氟比洛芬酯从脂微球中释放出来，在羧基酯酶作用下迅速水解生成氟比洛芬，通过氟比洛芬抑制前列腺素的合成而发挥镇痛作用。 2．毒理研究 生殖毒性：妊娠前及妊娠初期大鼠静脉内给予5mg/kg/天，出现排卵及着床减少；器官形成期静脉给药10μg/kg/天，出现伴有母体全身状态恶化的胎仔发育延迟，胎儿死亡率增加，哺乳能力降低及出生胎儿发育抑制。兔静脉给予80mg/kg/天，出现伴有母体全身状态恶化的流产、早产的增加及胎仔死亡率增加。 适应症 术后及癌症的镇痛。 用法用量 通常成人每次静脉给予氟比洛芬酯50mg，尽可能缓慢给药（1分钟以上），根据需要使用镇痛泵，必要时可重复应用。并根据年龄、症状适当增减用量。一般情况下，本品应在不能口服药物或口服药物效果不理想时应用。 包装规格： 50毫克/5毫升/支* 10支/盒 50毫克/5毫升/支* 50支/盒 生产商： 日本科研制药 原处方资料附件:http://www.info.pmda.go.jp/go/pack/1149407A1040_1_06/ ROPION Intravenous Injection 50mg（Flurbiprofen axetil，ロピオン静注） Brand name : ROPION Intravenous Injection 50mg 　Active ingredient: Flurbiprofen axetil 　Dosage form: Injection 　Print on wrapping:  Effects of this medicine This medicine inhibits the synthesis of substances (mainly prostaglandin) related to pain and inflammation, thereby relieving pain. It is usually used for relief of pains associated with various types of cancer and after surgery. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have peptic ulcer, blood abnormality, hepatic disorder, renal disorder, heart function abnormality, hypertention, aspirin asthma or history of it, bleeding tendency, bronchial asthma, ulcerative colitis or Crohn's disease. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, inject intravenously. It may be injected repeatedly, if necessary. •The treatment period with this medicine depends on your response to the treatment. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include nausea, itch and rash. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •cold sweat, breathing difficulty, hives [shock, anaphylactoid symptoms] •decrease of urine volume, swelling [acute renal failure, nephrotic syndrome] •abdominal pain, blood vomiting, blood discharge from the bowels [gastrointestinal hemorrhage] •high fever, conjunctival hyperemia, redness in wide range of skin [toxic epidermal necrolysis, oculomucocutaneous syndrome, exfoliative dermatitis] •wheezing, breathing difficulty [asthma attack] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Kaken Pharmacetical Co.,LtdInjection Revised: 4/2014 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.